Safety & Prevention Outcomes Study (SPOS)

University of Michigan

Status: Completed

Conditions: Opioid-Related Disorders; Drug Overdose

Treatments: Behavioral: TBI - Cohort 2; Behavioral: TBI - Cohort 1

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01894087

R49CE002099

Details and patient eligibility

About

Unintentional poisoning is a developing public health problem in the U.S. Unintentional poisoning (or "overdose") deaths increased 157% among adults between 1999 and 2008. There were ~700,000 emergency department (ED) visits due to overdoses in 2007. Medication-related overdoses, particularly prescription opioid overdoses, have accounted for much of this increase. There have been parallel increases in sales of opioids (with a 6 fold increase between 1997 and 2007), as well as both medical and non-medical use of prescription opioids. Prescription opioids are now among the most common of drugs used non-medically in the U.S.

The specific aims of this project are to: 1) Develop an ED-based tailored brief prescription opioid overdose prevention intervention. We will examine therapeutic alliance, perceived satisfaction, and perceived utility of the intervention; 2) Examine intervention effects on precursors of overdose risk behavioral change immediately post-intervention. We will compare intervention and control participants on knowledge, self-efficacy, readiness to change, and behavioral intentions regarding overdose risk behavior; and 3) Examine intervention effects on overdose risk behaviors six months post-intervention. We will compare intervention and control participants on: 1) use of high dose/quantity of opioids; 2) using opioids in combinations with certain psychoactive substances (i.e., alcohol, heroin, cocaine, and sedatives); and, 3) route of administration.

Enrollment: 204 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients 18-60 presenting to the ED for medical care
• ability to provide informed consent
• Additional criteria for intervention: past extramedical opioid use

Exclusion criteria

• patients who do not understand English
• prisoners
• patients classified by medical staff as a "Level 1" trauma (e.g., in need of immediate lifesaving procedures)
• patients deemed unable to provide informed consent
• patients treated in the ED for suicide attempt or sexual assault

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 4 patient groups

Therapist-led brief intervention (TBI) - Cohort 1

Active Comparator group

Description:

Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a "change plan" for each participant.

Treatment:

Behavioral: TBI - Cohort 1

Enhanced usual care - Cohort 1

No Intervention group

Therapist-led brief intervention (TBI) - Cohort 2

Active Comparator group

Description:

Participants will receive a therapist-led, computer-assisted intervention session with a master's level therapist. The interventions are designed to address extramedical prescription opioid use and overdose risk behaviors. This includes a review of the participants' strengths, values, and goals; feedback regarding their opioid use and overdose risk behaviors; developing a discrepancy between their opioid and other drug use and ability to meet goals and values; and the formulation of a "change plan" for each participant.

Treatment:

Behavioral: TBI - Cohort 2

Enhanced usual care - Cohort 2

No Intervention group